Z-0786-05

Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker...

Name: Z-0786-05 Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker...
Creator: Stryker Endoscopy
Published: 2005-02-08
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2005-02-08 / Terminated / root cause: manufacturing process

FDA source

Stryker Endoscopy began a recall of Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 on 2005-02-08. The reason FDA records is "The device has the potential to overheat and cause patient burns during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0786-05
Status: Terminated
Initiated: 2005-02-08
Posted: 2005-05-03
Terminated: 2005-05-20
Recalling firm: Stryker Corp.
Product: Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138
Product code: HRX Arthroscope
Reason for recall: The device has the potential to overheat and cause patient burns during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All consignees will be immediately notified via phone calls and a mailed Urgent Product Recall Notice (2 recipients per consignee, Risk Manager and OR Supervisor)
Quantity in commerce: 28935 boxes, 5 units per box.
Distribution: 740 domestic consignees
Product codes and lots: The following part numbers and subsequent lot numbers are involved in this recall. Part number 0275-950-000: 04109232, 0419292, 04109312, 04119712, 04119732, 04363AG2, 04364AG2. Part number 0275-951-012: 04098532, 04098752, 04098852, 04098872, 04109172, 04109212, 04109292, 4109312, 04119352, 04119392, 04119432, 04119712, 04129892,04129912, 04355AG2, 04357AG2, 04358AG2, 04363AG2. Part number 0275-951-012S1: 4098812, 04119672. Part number 0275-951-200: 04098492, 04362AG2. Part number 0275-952-000: 04108972, 04113432, 04129812, 05013AG2. Part number 0375-950-000: 0409522, 04112882, 04112962, 04123162. Part Number 0975-950-012: 04102542, 04102662, 04123162, 04123202. Part number 0375-951-012: 04092262, 4092362, 04092402, 04112862, 04112882, 04112902, 04113042, 04113082, 04123142, 04123202. Part Number 0375-951-200: 04113042. Part number 0275-950-012: 04098812, 04108912, 04109152, 04119512, 0411612, 0411712, 04129792, 04357AG2. Part Number 0275-951-000: 04098532, 04098552, 04098752, 04098772, 04098832, 04098852, 04098892, 04108912, 04109152, 04109172, 04109192, 04109232, 04109252, 04109292, 04119412, 04119432, 04119612, 04119632, 04119712, 04119732, 04129792, 04129852, 04129912, 04129972, 04352AG2, 04352AG2. Part Number 0375-951-000: 04092262, 4092362, 04102542, 04102662, 04102682, 04102762, 04112882, 04113002, 04113082, 04123162, 04123202, 04123222. Part number 0375-952-000: 04092522, 04102602, 04113042, 04123222.

Product code HRX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)